Comparing the effect of incentive spirometry and deep breathing exercises on hemodynamic parameters of patients undergoing coronary artery bypass grafting surgery
1Determining and comparing mean score of hemodynamic indices (systolic and diastolic blood pressure, heart rate, arterial oxygen saturation, respiratory rate) before intervention (preoperative) in patients in two groups of respiratory and incentive spirometry;2determining and comparing mean scores of hemodynamic indices on the first, second and third day after surgery in patients in two groups of breathing and incentive spirometry;3Comparing mean score of preoperative hemodynamic indices and the first, second and third postoperative days in respiratory training group;4Comparing mean scores of preoperative hemodynamic indices and first, second and third postoperative day in the incentive spirometry group; 5Comparing mean scores of changes in hemodynamic parameters before surgery and on the first, second and third day after surgery in patients in two groups of respiratory and incentive spirometry.
Design
A clinical trial with two intervention groups, parallel groups, non-double-blinded, and permuted-block randomization
Settings and conduct
Razi Hospital of Birjand, permuted-block randomization
Participants/Inclusion and exclusion criteria
No suffering of cognitive neuromuscular disorders
Non-emergency surgery
Ability to perform breathing exercises and to use incentive spirometry
Willingness to participate in the study
Re-surgery due to possible complications
Cognitive and neurological complications after surgery
Severe hemodynamic disorders (e.g., severe hypo- and hypertension, shock)
Severe lung disease (such as chronic obstructive pulmonary disease) Kidney dysfunction
Intervention groups
Deep breathing exercises
incentive spirometry
Main outcome variables
Gender; Age; Education; Marital status; Any record of suffering hypertension; Any record of suffering from diabetes; Any record of suffering of hyperlipidemia; Any record of smoking; Hemodynamic indices; Intervention method
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191028045267N1
Registration date:2020-03-12, 1398/12/22
Registration timing:retrospective
Last update:2020-03-12, 1398/12/22
Update count:0
Registration date
2020-03-12, 1398/12/22
Registrant information
Name
Fateme Zerang
Name of organization / entity
Islamic azad university of yazd
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1503
Email address
fateme.zerang2018@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-14, 1398/10/24
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of incentive spirometry and deep breathing exercises on hemodynamic parameters of patients undergoing coronary artery bypass grafting surgery
Public title
"Investigating the effect of incentive spirometry on hemodynamic parameters of patients undergoing coronary artery bypass grafting surgery""The effect of deep breathing exercises on hemodynamic parameters of patients undergoing coronary artery bypass grafting surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No suffering of cognitive neuromuscular disorders
Non-emergency surgery
Ability to perform breathing exercises and to use incentive spirometry
Willingness to participate in the study
Exclusion criteria:
Re-surgery due to possible complications
Cognitive and neurological complications after surgery
Severe hemodynamic disorders (e.g., severe hypo- and hypertension, shock)
Severe lung disease (such as chronic obstructive pulmonary disease)
Kidney dysfunction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups of breathing exercises (n = 20) and incentive spirometry (n = 20) via permuted-block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Islamic Azad University, Yazd Branch
Street address
Shohaday-e-Gomnam Blvd., Safaeieh D.C., Yazd City, Yazd Province
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.IAU.KHUSIF.REC.1398.271
Health conditions studied
1
Description of health condition studied
Patients Candidate for Coronary Artery Bypass Grafting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial Oxygen Saturation in Two Groups (Incentive Spirometry and Respiratory Exercise)
Timepoint
before surgery, before induction of anesthesia and on the first, second, and third days after surgery,
Method of measurement
A PC-66b pulse oximeter, made in China, was performed
2
Description
Respiratory rate in two groups (incentive spirometry and breathing exercises)
Timepoint
before surgery, before induction of anesthesia and on the first, second, and third days after surgery,
Method of measurement
Observing chest movements in a minute and counting it
3
Description
Systolic and diastolic blood pressure in two groups (incentive spirometry and breathing exercises)
Timepoint
Before surgery, before induction of anesthesia, and on the first, second, and third days after surgery
Method of measurement
As the instructions show, a mercury barometer with an appropriate armband size, while a patient is sitting on a comfortable chair with his/her hand on his/her heart, is measured twice in a 10-15 minute interval and the mean scores is recorded as an his/her blood pressure.
4
Description
Heart rate in two groups (incentive spirometry and breathing exercises)
Timepoint
Before surgery, before induction of anesthesia, and on the first, second, and third days after surgery
Method of measurement
A PC-66b pulse oximeter, made in China, was performed
Secondary outcomes
empty
Intervention groups
1
Description
Control group: incentive spirometry (One day before surgery, patients in the incentive spirometry group were trained on how to use incentive spirometry to ensure that the researcher performed them correctly. Applying a spiral tube to the mouth, he/she inhaled inside the device in a sitting or semi-sitting posture, holding his/her breath for three seconds, and slowly exhaled by removing the device. Patients were asked that each time they increased breathing, they gradually took deeper breaths. This exercise was repeated for 10 deep breaths, every two hours at waking time. These interventions began one hour after the endotracheal tube was removed by the researcher’s supervision or her colleague’s and continued for up to three days after surgery. Hemodynamic parameters were measured and recorded on the first, second, and third days postoperatively.
Category
Prevention
2
Description
Breathing exercises (One day before surgery, patients in the breathing exercises group were trained on how to perform deep scheduled breathing exercises so that the researcher ensures it is performed accurately. Scheduled deep breathing exercises were trained such that a patient is in a sitting or semi-sitting posture, performing slow, deep breathing through the nose, while simultaneously placing his/her hands on the chest to relieve pain and breathing more easily, and after inhalation, holds his/her breath for three seconds. Then he/she exhales through the mouth while the lips and the abdominal muscles are squeezed. He/she must repeat this exercise for a ten times every two hours at waking time. These interventions began one hour after the endotracheal tube was removed by a researcher or her colleague and continued for up to three days after surgery. Hemodynamic parameters were measured and recorded on the first, second, and third days postoperatively.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Fateme Zerang
Street address
No. 18,Yas Ave, Qafari Ave
City
Birjand
Province
South Khorasan
Postal code
9719866838
Phone
+98 56 3234 1503
Email
fatme.zerang2018@gmil.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masome Barkhordari
Street address
Shohaday-e-Gomnam Blvd., Safaeieh D.C., Yazd City, Yazd Province
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Email
Barkhordary.m@gmail.com
Web page address
https://www.iauyazd.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Zerang
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 18,Yas Ave, Qafari Ave
City
Birjand
Province
South Khorasan
Postal code
9719866838
Phone
+98 56 3234 1503
Email
fateme.zerang2018@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Zerang
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 18, Yas Ave, Qafari Ave
City
Birjand
Province
South Khorasan
Postal code
9719866838
Phone
+98 56 3234 1503
Email
fateme.zerang2018@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Zerang
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 18 ,Yas Ave, Qafari Ave
City
Birjand
Province
South Khorasan
Postal code
9719866838
Phone
+98 56 3234 1503
Email
fateme.zerang2018@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available